FDA 510(k) Application Details - K023824

Device Classification Name	Test, Albumin Cobalt Binding   More FDA Info for this Device
510(K) Number	K023824
Device Name	Test, Albumin Cobalt Binding
Applicant	ISCHEMIA TECHNOLOGIES, INC. 4600 WEST 60TH AVE. ARVADA, CO 80003 US Other 510(k) Applications for this Company
Contact	PETER CROSBY Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	NJV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2002
Decision Date	02/14/2003
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review